医学
临床终点
肺癌
外科
随机对照试验
全肺切除术
癌症
临床试验
内科学
作者
Kenichi Nakamura,Hisashi Saji,R. Nakajima,M. Okada,Hisao Asamura,Tatsuhiro Shibata,Shinichiro Nakamura,Hirohito Tada,Masahiro Tsuboi
摘要
A Phase III study was started in Japan to evaluate the non-inferiority in overall survival of segmentectomy compared with lobectomy in patients with small-sized (diameter =2 cm) peripheral non-small cell lung cancer, excluding radiologically determined non-invasive cancer. This study began in August 2009, and a total of 1100 patients will be accrued from 71 institutions within 3 years. The primary endpoint is overall survival. The secondary endpoints are post-operative respiratory function, relapse-free survival, proportion of local recurrence, adverse events, proportion of patients who complete segmentectomy, duration of hospitalization, duration of chest tube placement, operation time, blood loss and number of auto-sutures used. This study is one of the first intergroup studies in Japan between the Japan Clinical Oncology Group and the West Japan Oncology Group.
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